BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18044533 · Received October 31, 2023

    Report

    Report Number
    3012236936-2023-02756
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    February 15, 2023
    Report Date
    November 12, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531819
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT PRE-OPERATIVE VISION INFORMATION: UNCORRECTED VISUAL ACUITY (UCVA) 20/100. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS A-4 PATIENT WEIGHT AND A-5 PATIENT ETHNICITY AND RACE: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION H3-81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AFTER THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), THERE WAS REPORTEDLY A SMALL IRREGULARITY OUTSIDE OF THE OPTIC THAT COULD NOT BE POLISHED OFF. THE IOL REMAINS IMPLANTED AS THE SMALL IRREGULARITY WAS VISUALLY INSIGNIFICANT AND THE PATIENT HAS NOT REPORTED ANY VISUAL ISSUES RELATED TO THE SMALL IRREGULARITY. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY HOWEVER, THERE WAS NO INCISION ENLARGEMENT, MEDICAL ATTENTION, MEDICATION PRESCRIBED, SUTURE(S), OR VITRECTOMY. THERE ARE NO PLANS FOR MEDICAL/SURGICAL INTERVENTION TO ADDRESS THE SMALL IRREGULARITY. POST-OPERATIVE VISION WAS REPORTED AS: 1D - UC 20/30 / 1W - BC 20/20, PRE-OPERATIVE VISION INFORMATION, HOWEVER, IS UNKNOWN. PATIENT'S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED AND SHE HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141777 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531819

    Patients

    Seq Age Sex Outcome Treatment
    1 Female